FDA Warning Letter Targets Erectin Stimulating Gel and VigRX Delay Wipes
FDA issued a warning letter to Leading Edge Health Inc. after reviewing the company’s website and determining that two sexual health products were being marketed as unapproved new drugs.
The products identified were “Erectin Stimulating Gel” and “VigRX Delay Wipes.” FDA cited website claims such as “INSTANT ERECTION formula,” “Rock Hard Erections,” and “Longer-Lasting Erections” as evidence that the products were intended to affect the structure or function of the body.
FDA also cited claims for VigRX Delay Wipes related to premature ejaculation, including references to numbing effects and blood circulation.
Because the products were marketed with drug-like claims but did not have FDA-approved applications, FDA concluded they were unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.
The warning letter directed the firm to respond within 15 business days with corrective actions and measures to prevent recurrence.
MDP Perspective
This warning letter is a useful reminder that product classification is driven by intended use, not by how a company wishes to position a product. Website language, product names, promotional claims, and implied benefits can all create drug status.
For companies marketing sexual health, wellness, or performance products, aggressive claims can quickly move a product from cosmetic or supplement positioning into drug territory. Once that happens, FDA expects an approved drug application or a clear legal marketing pathway.
Links
Warning letter to Leading Edge Health, Inc.
Warning Letter to Wild Arabic Herbs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales
FDA Warns Wild Arabic Herbs Over Product Cancer Claims
FDA Warns Wild Arabic Herbs Over Cancer Claims for Herbal Product FDA issued a warning letter to Wild Arabic Herbs after reviewing the company’s website and determining that its “Edral-17t” product was marketed as an unapproved new drug. FDA cited claims that the...
FDA Warns Amazon for Unapproved Drugs Sold On Its Website
FDA Issues Warning Letter to Amazon for Unapproved Drug Products FDA issued a warning letter to Amazon.com, Inc. after purchasing and reviewing products sold through Amazon’s website and fulfilled through Amazon’s logistics network. The products identified were...
FDA Targets Online Marketing of Unapproved Drugs
FDA Issues 14 Warning Letters Targeting Online Unapproved Drug Sales The U.S. Food and Drug Administration (FDA) has issued a coordinated series of warning letters targeting companies marketing unapproved drug products online, signaling an intensified enforcement...
FDA Approves First Treatment to Reduce Risk of Acute Pancreatitis
FDA Approves First Treatment Proven to Reduce Acute Pancreatitis Risk in Severe HypertriglyceridemiaAn important example of the distinction between surrogate endpoints and clinical outcomes in drug development The U.S. Food and Drug Administration (FDA) has approved...
One Contaminated Alcohol Pad, Multiple Recalls
A Lesson in Medical Device Supply Chain Quality At first glance, Cardinal Health's recent recall of Webcol™ Alcohol Prep Pads appears straightforward. A commonly used healthcare product was found to be contaminated with Paenibacillus phoenicis, creating a potential...
Early Alert: Windstone Medical Recall for Convenience Kits
FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal...
